Manufacturing quality engineering

Quality EngineerOverviewA global medical device organization is seeking a Quality Engineer to support a major manufacturing capacity expansion program in Jacksonville, FL. This project involves the transfer and qualification of production lines into the Jacksonville facility, supporting growth across manufacturing operations.The Quality Engineer will primarily support equipment qualification and validation activities, working alongside established senior SMEs who will provide guidance, training, and technical oversight.ResponsibilitiesSupport equipment qualification activities for transferred and newly installed manufacturing equipmentReview validation documentation and protocols (not responsible for authoring protocols)Participate in:Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Process Validation activitiesRisk assessmentsProcedural revisions and updatesWork closely with Quality, Engineering, Manufacturing, and Validation teams during equipment startup and qualificationSupport deviation investigations and validation execution activities as requiredEnsure compliance with applicable quality and regulatory standardsRequired Experience1-5 years of Quality Engineering, Validation Engineering, or similar experience within a regulated manufacturing environmentExperience supporting:IQ/OQ/PQ activitiesEquipment qualificationValidation reviewsRisk assessmentsUnderstanding of GMP, validation, and quality system requirementsExperience within a regulated industry such as:Medical DevicePharmaceuticalsBiotechnologyAutomotiveAerospaceOther highly regulated manufacturing environmentsPreferred ExperienceComputer System Validation (CSV) exposureExperience validating:Automated or semi-automated manufacturing equipmentProduction recipesUser access controlsAlarm management systemsExperience supporting manufacturing line transfers, scale-up programs, or capacity expansion projectsEOE Statement: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.